Drug product
clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 441 108 INDIA, NDC 68180-492-01
D-0377-2025
Product summary
- Event
- Event 96681
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2724 bottles
- Official record key
drug-enforcement:D-0377-2025
Official wording
Reason: Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
Code information: Lot #: M300442, Exp Date: 6/30/2025
Distribution pattern: USA nationwide
Derived failure modes
-
Potency or specification failure
out of specification